Nicotine and Caffeine Pouches for Fatigue
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how nicotine and caffeine pouches affect physical performance, cognitive skills, heart health, and appetite in healthy men. Researchers aim to determine differences between using nicotine pouches, caffeine pouches, both together, or a placebo. Participants will use these oral pouches and engage in cycling, cognitive, and balance tests while various health measurements are recorded. The trial seeks fit men aged 21-40 who exercise moderately or vigorously for at least 150 minutes a week. As an unphased trial, it offers participants the chance to contribute to understanding the effects of common substances on health and performance.
Will I have to stop taking my current medications?
The trial requires that you stop taking any supplements or medications that might interfere with the study results, and you cannot take medications that negatively interact with caffeine or nicotine.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have found caffeine pouches to be generally safe for most healthy adults if total caffeine intake stays below 400 mg a day. However, they can cause side effects like jitteriness, anxiety, or a racing heart due to rapid caffeine absorption.
Nicotine pouches commonly cause side effects such as nausea, fatigue, or headaches. Although cases of nicotine poisoning have occurred, none were severe. Excessive nicotine can be harmful, so caution is necessary.
When combined, nicotine and caffeine might help with nicotine withdrawal and improve movement, according to research. However, both substances can cause side effects, which may intensify when used together. More research is needed to fully understand the effects of using both in pouches.
Overall, while these pouches are generally safe, they carry risks, and users should monitor their usage carefully.12345Why are researchers excited about this trial's treatments?
Unlike traditional treatments for fatigue, such as lifestyle changes, sleep therapies, and medications like stimulants or antidepressants, these new oral pouches offer a unique approach. Researchers are excited about these treatments because they combine the familiar stimulants nicotine and caffeine in an innovative delivery method. The oral pouches provide a quick and convenient way to potentially boost energy levels without needing complex regimens or prescriptions. The combination pouch, delivering both nicotine and caffeine simultaneously, could amplify the energy-boosting effects more efficiently than current options.
What evidence suggests that this trial's treatments could be effective for fatigue?
This trial will evaluate the effects of different oral pouches on fatigue. Participants may receive oral caffeine pouches, which studies have shown can significantly improve physical performance by extending exercise duration and reducing tiredness. Caffeine also enhances thinking and decision-making, providing more mental energy. Another group will receive oral nicotine pouches, which research indicates do not significantly aid endurance but can improve skills requiring precise movements and boost short-term memory. Some participants will receive a combination of both nicotine and caffeine pouches, which may help maintain alertness and improve mood and movement, especially during withdrawal symptoms. Overall, both caffeine and nicotine offer unique benefits that could enhance performance and cognitive abilities.26789
Who Is on the Research Team?
Austin J Graybeal, PhD
Principal Investigator
University of Southern Mississippi
Are You a Good Fit for This Trial?
This trial is for non-obese adult males aged 21-40 who want to participate in a study evaluating the effects of nicotine and caffeine pouches on physical performance, brain function, heart health, and appetite. Participants must be willing to use oral pouches and complete various tests.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral nicotine and caffeine pouches or placebo and complete anaerobic cycling, cognitive, and balance tests
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Oral Pouch - Caffeine
- Oral Pouch - Nicotine
- Oral Pouch - Placebo
Trial Overview
The study is testing how oral nicotine pouches, caffeine pouches, both combined, or placebo affect anaerobic performance (like cycling speed), cognition (thinking skills), cardiovascular/autonomic function (how the heart works), and food intake.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Single dose 3mg oral nicotine pouch
Single dose 100mg oral caffeine pouch
Single simultaneous doses of a 3mg oral nicotine pouch and a 100mg oral caffeine pouch
Flavor, color, and appearance matched placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Southern Mississippi
Lead Sponsor
Citations
The Effect of a Caffeine and Nicotine Combination on Nicotine ...
The results showed that a combination of caffeine and nicotine could effectively relieve nicotine withdrawal syndrome, increase movement ...
2.
researchgate.net
researchgate.net/publication/227750679_Effects_of_nicotine_and_caffeine_separately_and_in_combination_on_EEG_topography_mood_heart_rate_cortisol_and_vigilanceEffects of nicotine and caffeine, separately and in ...
Level of depressive mood depended on an interaction of caffeine and nicotine. Vigilance performance was enhanced significantly by caffeine and ...
Effects of Oral Nicotine and Caffeine Pouches on - ClinConnect
This small, early-stage study is looking at how single-dose oral pouches containing nicotine, caffeine, or both affect exercise performance, thinking, mood, ...
How Safe Are Caffeine Pouches?
More studies are needed to determine the precise impact of nicotine or caffeine pouches on oral health, but dentists generally urge caution.
The Effects of Oral Nicotine Pouches on Cigarette Smoking ...
Compared to lower nicotine strength pouches, higher nicotine strength pouches may have greater impact on smoking behavior and adults who smoke ...
Oral nicotine pouches with an aftertaste? Part 1
Three substances were classified by International Agency for Research on Cancer as possibly carcinogenic to humans. The two nicotine-free ...
The Effect of a Caffeine and Nicotine Combination on ...
The results showed that a combination of caffeine and nicotine could effectively relieve nicotine withdrawal syndrome, increase movement ability ...
8.
theconversation.com
theconversation.com/caffeine-pouches-deliver-a-fast-hit-and-hidden-risks-263933Caffeine pouches deliver a fast hit – and hidden risks
And because the drug is absorbed so quickly, side-effects, such as jitteriness, anxiety, insomnia and heart palpitations, can hit harder.
9.
accessdata.fda.gov
accessdata.fda.gov/static/searchtobacco/ZYN/PMTA_TPL_PM593-PM612_Zyn_01_13_2025_Redacted.pdfTPL Review of PMTAs - accessdata.fda.gov
The evidence related to appeal and intentions to use the new products, combined with observational data on youth use of nicotine pouches, ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.